Phase II Trial Evaluating The Efficacy Of A Multiepitope Dendritic Cell Vaccine Given With Trastuzumab And Vinorelbine For The Treatment Of Women With Metastatic Breast Cancer That Express HLA-A0201
therapeutic autologous dendritic cells
+ trastuzumab
+ vinorelbine ditartrate
Maladies du sein+2
+ Néoplasmes du sein
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the efficacy of multiepitope autologous dendritic cell vaccine, trastuzumab (Herceptin\^®), and vinorelbine by measuring the change in the largest dimension of metastatic lesions, in women with locally recurrent or metastatic breast cancer that does not overexpress human epidermal growth factor receptor 2 (HER2)/neu. Secondary * Determine the ability of this regimen to induce functional antigen-specific T cells in these patients by measuring ex-vivo antigen-specific T-cell activity against peptide-pulsed dendritic cells and tumor targets by tetramer staining and intracellular cytokine assays. OUTLINE: * Autologous dendritic cell mobilization and harvest: All patients undergo autologous dendritic cell mobilization with filgrastim (G-CSF) and/or sargramostim (GM-CSF) subcutaneously daily for 4 days followed by apheresis. Mobilized peripheral blood is processed for the production of dendritic cells by cluster of differentiation (CD)34-positive cell selection. The dendritic cells are expanded and then pulsed with E75 and E90 peptides. * Treatment: Patients receive vinorelbine IV over 6-10 minutes and trastuzumab (Herceptin \^®) IV over 90 minutes on day 1. Patients also receive autologous dendritic cells pulsed with E75 and E90 peptides subcutaneously over 2-5 minutes on day 1\*. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Note: \*If treatment is given locally, the vaccine therapy will be given at University of North Carolina (UNC) -Chapel Hill the following day. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.56 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 120 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Locally recurrent or metastatic disease * HLA-A0201 positive by DNA genotyping * HER2/neu expression at least 1+ by immunohistochemistry of tumor sample * Central Nervous System (CNS) metastases allowed provided on therapy for 3 months and stable * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hematocrit \> 33% Hepatic * Transaminases ≤ 3 times upper limit of normal * Bilirubin ≤ 2 times normal * Hepatitis B surface antigen negative Renal * Creatinine \< 2.0 mg/dL Cardiovascular * Ejection fraction \> 45% by multigated acquisition scan (MUGA) OR * Left ventricular function normal by echocardiogram * No serious cardiac condition that would preclude study participation or compliance Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No serious medical or psychiatric condition that would preclude study participation or compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Prior biologic therapy allowed Chemotherapy * More than 30 days since prior cytotoxic chemotherapy * No other concurrent chemotherapy Endocrine therapy * More than 30 days since prior hormonal therapy * No concurrent hormonal therapy * No concurrent systemic steroids Radiotherapy * Not specified Surgery * Not specified Other * Concurrent bisphosphonates for bone metastases allowed
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, United StatesVoir le site